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NCT04697628 · ClinicalTrials.gov registry record · Phase 3

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

A Phase 3 study of Cervical Cancer, sponsored by Seagen, a wholly owned subsidiary of Pfizer.

Completed
Registry status
Phase 3
Development phase
502
Enrollment target
20
Study locations

NCT04697628 is a Phase 3 study of Cervical Cancer that has completed, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 502 participants, below the 567-participant average among 144 other Cervical Cancer trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT04697628, a Phase 3 study of Cervical Cancer, has completed, sponsored by Seagen, a wholly owned subsidiary of Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
502 participants
Enrollment target
20
Study locations

Study Summary

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

Conditions Studied

Interventions

  • DRUG gemcitabine
  • DRUG vinorelbine
  • DRUG topotecan
  • DRUG tisotumab vedotin
  • DRUG irinotecan

Study Locations (20)

Kentucky

  • Norton Cancer Institute, Downtown - Louisville
  • Norton Hospital - Louisville
  • Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD - Louisville
  • Norton Cancer Institute, St. Matthews Campus - Louisville
  • Norton Cancer Institute - Louisville
  • Norton Women's & Children's Hospital - Louisville

Arizona

  • Arizona Oncology Associates, PC - HAL - Glendale
  • Arizona Oncology Associates P.C. - NAHOA - Phoenix
  • Arizona Oncology Associates, PC - HAL - Phoenix
  • Arizona Oncology Associates, PC - HAL - Scottsdale
  • Arizona Oncology Associates, PC - HAL - Tempe

California

  • University of California Irvine Health - Irvine
  • UC Irvine Health (Investigator Site File Location) - Orange
  • University of California Irvine Health - Orange
  • Olive View - UCLA Medical Center - Sylmar

Illinois

  • Northwestern Medical Group - Chicago
  • Northwestern Memorial Hospital - Chicago

Connecticut

  • Yale University School of Medicine - New Haven

Florida

  • Broward Health Medical Center - Fort Lauderdale

Georgia

  • Georgia Cancer Center at Augusta University - Augusta

Trial Details

FieldValue
Enrollment Target 502 participants
Start Date 2021-02-22
Est. Completion 2026-01-15
Phase Phase 3

What the Registry Record Tells You About NCT04697628

The ClinicalTrials.gov registry entry for NCT04697628 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 502 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 567-participant average among 144 other Cervical Cancer trials with a reported enrollment target (11% lower). The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cervical Cancer appearing as the primary indexed condition, and to 5 interventions - of which gemcitabine is the first listed.

NCT04697628 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Kentucky, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT04697628 about?

NCT04697628 is a clinical study titled "Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer". This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will...

What is the current status of trial NCT04697628?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 502 participants. The study started on 2021-02-22. Estimated completion is 2026-01-15.

What conditions does trial NCT04697628 study?

This clinical trial studies the following conditions: Cervical Cancer.

What interventions are being tested in trial NCT04697628?

The interventions under investigation include: gemcitabine (DRUG), vinorelbine (DRUG), topotecan (DRUG), tisotumab vedotin (DRUG), irinotecan (DRUG).

Who is sponsoring clinical trial NCT04697628?

This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04697628 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.